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Dermira (DERM), UCB Group (UCBJF.PK) Release: New CIMZIA (Certolizumab Pegol) Findings Presented At European Academy Of Dermatology And Venereology (EADV) Congress



9/14/2017 8:22:27 AM

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  • Presentations included the first 48-week data from the CIMPASI-1 and CIMPASI-2 psoriasis trials, and re-randomized data through 48 weeks from the CIMPACT psoriasis trial 1,2
  • Treatment with CIMZIA was associated with significant and clinically meaningful improvements in quality of life and work productivity 3,4
  • No new safety signals were observed in the psoriasis trials and the safety profile remains consistent with CIMZIA’s other indications
  • Additional presentations highlighted findings from the CRIB and CRADLE studies, demonstrating that CIMZIA, the only Fc-free, PEGylated anti-TNF, had minimal to no placental transfer and minimal to no transfer in breast milk 5,6

BRUSSELS, Belgium and MENLO PARK, Calif., Sept. 14, 2017 (GLOBE NEWSWIRE) -- UCB (Euronext:UCB) and Dermira, Inc. (NASDAQ:DERM) today announced new 48-week data from three Phase 3 trials evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis, which were presented in poster presentations during the 26th European Academy of Dermatology and Venereology (EADV) Congress, taking place in Geneva, Switzerland, September 13-17.

New 48-week safety and efficacy data from the CIMPASI-1, CIMPASI-2 and CIMPACT trials were presented, as well as patient-reported outcomes including quality of life as defined by the Dermatology Quality of Life (DLQI) and work productivity and activity impairment (WPAI) measures. CIMPASI-1 and CIMPASI-2 are randomized, blinded, parallel group, placebo-controlled, multi-center trials that have previously reported statistically and clinically significant improvements at week 16 in adult patients with moderate-to-severe chronic plaque psoriasis treated with CIMZIA compared to placebo. CIMPACT is a randomized, blinded, parallel group, placebo- and active-controlled, multi-center trial that demonstrated clinically significant improvements in skin severity at 12 weeks in patients receiving CIMZIA versus placebo. Data from all three studies demonstrated that the clinical benefit was maintained through 48 weeks in patients who responded at week 16.

Additionally, improvements in DLQI and WPAI patient-reported outcomes were demonstrated in all three trials at week 16 and maintained through week 48 in patients who responded at week 16. DLQI is a widely used and recognized quality of life measurement instrument used across several dermatological diseases. 7 The WPAI looks at the effect of dermatological conditions on factors affecting work productivity and activity impairment, which include absenteeism and work productivity loss, among others.

Based on these data, in July 2017, UCB and Dermira announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), and a separate submission to the European Medicines Agency (EMA), to expand the approved indications for CIMZIA to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

“Data from the CIMZIA Phase 3 clinical program present a compelling picture of CIMZIA’s potential clinical benefit to patients living with chronic plaque psoriasis, a common and often debilitating immune-mediated inflammatory disorder affecting the skin,” said Luis Peña, chief development officer of Dermira. “These positive findings support our belief that, if approved, CIMZIA could represent an important new treatment option for psoriasis patients.”

Results from the UCB-sponsored CRIB study, a prospective pharmacokinetic study showing minimal to no placental transfer of CIMZIA from mother to fetus during pregnancy, and from CRADLE, a prospective pharmacokinetic study, which found minimal to no transfer of CIMZIA into breast milk, were presented in an oral presentation. Both studies included a safety evaluation.

The CRIB and CRADLE studies included women with rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS), and Crohn’s disease (CD) – chronic inflammatory diseases (CID) that often affect women of child bearing age. Adequate disease control in these diseases is crucial to ensure optimal infant and maternal health, yet many women with CID face inadequate disease control before pregnancy and experience disease flares during and after pregnancy.8 These women often have limited options when making treatment decisions during pregnancy and lactation due to the potential associated health risks for fetuses and infants. These women often face uncertainty regarding the use of biologics during pregnancy and breastfeeding.9 The potential role of CIMZIA in these women will be evaluated for moderate-to-severe chronic plaque psoriasis.

“UCB is executing on its Patient Value Strategy to connect the unmet needs of patients with innovative science. Psoriasis has a significant emotional and physical impact on patients, and there is still a need for new therapies to more effectively control skin symptoms. Additionally, women of childbearing age with immune disease are often in the difficult position of navigating treatment for their condition and pregnancy. Developing CIMZIA in psoriasis and conducting the CRIB and CRADLE studies, which provide critical information for physicians and women as they plan for pregnancy and appropriate disease management, are important advancements in addressing these unmet needs for patients,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.

Following is a guide to co-sponsored data presentations:

[P1969]: Maintenance of Response With Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results of a 32-Week Re-Randomized Maintenance Period From an Ongoing Phase 3, Multicenter, Randomized, Active- and Placebo-Controlled Study (CIMPACT)
Augustin, M. et al.

  • Date/Time: Wednesday 13 September, 08:00 - 16:00 CEST
  • Session Info: Psoriasis (e-Poster presentation)

[P1967]: Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: DLQI and WPAI Patient-Reported Outcomes From an Ongoing Phase 3, Multicenter, Randomized, Active- and Placebo-Controlled Study (CIMPACT)
Piguet, V. et al.

  • Date/Time: Wednesday 13 September, 08:00 - 16:00 CEST
  • Session Info: Psoriasis (e-Poster presentation)

[P1973]: Maintenance of Response With Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: 48-Week Results From Two Ongoing Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2)
Reich, K. et al.

  • Date/Time: Wednesday 13 September, 08:00 - 16:00 CEST
  • Session Info: Psoriasis (e-Poster presentation)

[P1971]: Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: DLQI and WPAI Patient-Reported Outcomes From Two Ongoing Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2)
Thaçi, D. et al.

  • Date/Time: Wednesday 13 September, 08:00 - 16:00 CEST
  • Session Info: Psoriasis (e-Poster presentation)

Following is a guide to UCB-sponsored data presentations:

[FC04.03]: Lack of Placental Transfer of Certolizumab Pegol During Pregnancy: Results from CRIB, a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study
Mariette, X. et al.

  • Date/Time: Thursday 14 September, 15:20 -15:30 CEST
  • Session Info: Free communications in therapy (Free communication); Room F

[OP01.02]: Minimal to No Transfer of Certolizumab Pegol into Breast Milk: Results from CRADLE, a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study
Clowse, M. E. B. et al.

  • Date/Time: Thursday 14 September, 11:00 -11:10 CEST
  • Session Info: Therapies (Oral e-Poster presentation); Room Q

About Psoriasis
Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the world’s population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.

About UCB and Dermira
The Phase 3 CIMZIA clinical development program in psoriasis was led by Dermira, Inc., in collaboration with UCB as the regulatory sponsor. Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the United States, Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the United States and Canada. UCB will retain marketing rights for CIMZIA in the U.S. and Canada for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ankylosing spondylitis. In the rest of world, UCB retains marketing rights for CIMZIA for all approved indications, including psoriasis, subject to approval.

About Cimzia® in the US
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.

Important Safety Information about Cimzia® in the US

Risk of Serious Infections and Malignancy

Patients treated with Cimzia® are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Cimzia® should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Cimzia® use and during therapy. Treatment for latent infection should be initiated prior to Cimzia® use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Cimzia® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cimzia®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia® is a member. Cimzia® is not indicated for use in pediatric patients.

Patients treated with Cimzia® are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with Cimzia® should not be initiated in patients with an active infection, including clinically important localized infections. Cimzia® should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with Cimzia® should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

Malignancies

During controlled and open-labeled portions of Cimzia® studies of Crohn’s disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 Cimzia®-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of Cimzia® for Crohn’s disease and other investigational uses, there was one case of lymphoma among 2,657 Cimzia®-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In Cimzia® RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy =18 years of age), of which Cimzia® is a member. Approximately half of the cases were lymphoma (including Hodgkin’s and non-Hodgkin’s lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including Cimzia®. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohn’s disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with Cimzia®, especially in these patient types.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including Cimzia®. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.

Heart Failure

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cimzia® has not been formally studied in patients with CHF. Exercise caution when using Cimzia® in patients who have heart failure and monitor them carefully.

Hypersensitivity

Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following Cimzia® administration. Some of these reactions occurred after the first administration of Cimzia®. If such reactions occur, discontinue further administration of Cimzia® and institute appropriate therapy.

Hepatitis B Reactivation

Use of TNF blockers, including Cimzia®, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with Cimzia®. Exercise caution in prescribing Cimzia® for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue Cimzia® and initiate effective anti-viral therapy with appropriate supportive treatment.

Neurologic Reactions

Use of TNF blockers, including Cimzia®, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with Cimzia®. Exercise caution in considering the use of Cimzia® in patients with these disorders.

Hematologic Reactions

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia®. Consider discontinuation of Cimzia® therapy in patients with confirmed significant hematologic abnormalities.

Drug Interactions

An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of Cimzia® in these combinations. Therefore, the combination of Cimzia® with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with Cimzia®. There is no evidence that Cimzia® therapy has an effect on in vivo coagulation. Cimzia® may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

Autoimmunity

Treatment with Cimzia® may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.

Immunizations

Do not administer live vaccines or live-attenuated vaccines concurrently with Cimzia®.

Adverse Reactions

In controlled Crohn’s clinical trials, the most common adverse events that occurred in =5% of Cimzia® patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% Cimzia®, 13% placebo), urinary tract infection (7% Cimzia®, 6% placebo), and arthralgia (6% Cimzia®, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for Cimzia® and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in =3% of patients taking Cimzia® 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% Cimzia®, 2% placebo), headache (5% Cimzia®, 4% placebo), hypertension (5% Cimzia®, 2% placebo), nasopharyngitis (5% Cimzia®, 1% placebo), back pain (4% Cimzia®, 1% placebo), pyrexia (3% Cimzia®, 2% placebo), pharyngitis (3% Cimzia®, 1% placebo), rash (3% Cimzia®, 1% placebo), acute bronchitis (3% Cimzia®, 1% placebo), fatigue (3% Cimzia®, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving Cimzia® than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving Cimzia® 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving Cimzia® 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for Cimzia® and 2.5% for placebo.

The safety profile for patients with Psoriatic Arthritis (PsA) treated with CIMZIA® was similar to the safety profile seen in patients with RA and previous experience with Cimzia®.

The safety profile for AS patients treated with Cimzia® was similar to the safety profile seen in patients with RA.

For full prescribing information, please visit www.ucb.com

CIMZIA® is a registered trademark of the UCB Group of Companies.

About Cimzia® in the EU/EEA
In the EU, Cimzia® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Cimzia®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

  • Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
  • Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.4

Important Safety Information about Cimzia® in the EU/EEA
Cimzia® was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia® due to adverse events vs. 2.7% for placebo.

Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia®. Treatment with Cimzia® must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia® if infection becomes serious. Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia®.

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. Carriers of HBV who require treatment with Cimzia® should be closely monitored and in the case of HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.


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